Pediacare Childrens Allergy

Dosage form: liquid
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 12.5mg in 5mL
Labeler: Blacksmith Brands, Inc.
NDC Code: 52183-399

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

PediaCare Childrens Allergy

PediaCare Children’s Allergy Cherry Flavor

Drug Facts

Active ingredient

(in each 5 mL)*

Diphenhydramine HCI 12.5 mg

Purpose

Antihistamine/cough suppressant

*5 mL = one teaspoon

Uses
  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
  • runny nose
  • sneezing
  • itchy, watery eyes
  • temporarily relieves cough due to inhaled irritants

Warnings

Do not use
  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use

if the child has

  • persistent or chronic cough such as occurs with asthma
  • cough accompanied by excessive phlegm (mucus)
  • a breathing problem such as chronic bronchitis
  • glaucoma

Ask a doctor or pharmacist before use

if the child is taking sedatives or tranquilizers

When using this product
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • sedatives and tranquilizers may increase drowsiness

Stop use and ask a doctor if
  • cough gets worse or lasts for more than 7 days
  • cough tends to come back or occurs with fever, rash or headache that lasts

These could be signs of a serious condition.

Keep out of reach of children

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions
  • find right dose on chart below
  • use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
  • if needed, repeat dose every 4 hours
  • do not use more than 6 times in 24 hours
Age (yr)Dose (tsp)
Under 4 yearsDo not use
4 to 5 yearsDo not use unless directed by a doctor
6 to 11 years1 teaspoonful

Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Other information
  • each teaspoon contains: sodium 14 mg
  • store between 20-25°C (68-77°F). Protect from light. Store in outer carton until contents used.
  • do not use if bottle wrap, or foil inner seal imprinted “Safety Seal®” is broken or missing
  • see bottom panel for lot number and expiration date

Inactive ingredients

anhydrous citric acid, D&C red #33, FD&C red #40, flavors, glycerin, monoammonium glycyrrhizinate, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sucrose

Questions or comments?

call 1-888-474-3099

PediaCare Children’s Allergy Bubblegum Flavor

Drug Facts

Active ingredient

(in each 5 mL, 1 teaspoon)

Diphenhydramine HCI 12.5 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat

Warnings

Do not use
  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use

if the child has

  • glaucoma
  • a breathing problem such as chronic bronchitis

Ask a doctor or pharmacist before use

if the child is taking sedatives or tranquilizers

When using this product
  • marked drowsiness may occur
  • sedatives and tranquilizers may increase drowsiness
  • excitability may occur, especially in children

Keep out of reach of children

In case of overdose, seek professional assistance or contact a Poison Control Center (1-800-222-1222) immediately. 

Directions
  • use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
  • take every 4 to 6 hours
  • do not take more than 6 doses in 24 hours
  • tsp = teaspoon, mL = milliliter, mg = milligram
Age (yr)Dose (tsp)
children 6 to 11 years1 to 2 teaspoonfuls (5 mL to 10 mL)
children 4 to 5 yearsDo not use unless directed by a doctor
children under 4 yearsdo not use

Other information
  • each teaspoon contains: sodium 6 mg
  • store at room temperature

Inactive ingredients

citric acid, flavors, glycerin, poloxamer 407, purified water, red 33, red 40, sodium benzoate, sodium chloride, sodium citrate, sugar

Questions or comments?

call 1-888-474-3099

Principal Display Panel

See New Warnings & Directions
PediaCare® Children’s Allergy
Diphenhydramine HCI oral solution
Antihistamine/Cough suppressant

Cherry Flavor Liquid 4 FL OZ (118 mL)

Principal Display Panel

NO ACETAMINOPHEN
PediaCare® Children’s Allergy
Diphenhydramine HCI Oral Solution Antihistamine 
BubbleGum Flavor 4 FL OZ (118 mL)

PEDIACARE CHILDRENS ALLERGY 
diphenhydramine hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52183-399
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
D&C RED NO. 33 
FD&C RED NO. 40 
GLYCERIN 
GLYCYRRHIZIN, AMMONIATED 
POLOXAMER 407 
WATER 
SODIUM BENZOATE 
SODIUM CHLORIDE 
SODIUM CITRATE 
SUCROSE 
Product Characteristics
ColorREDScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:52183-399-041 BOTTLE (1 BOTTLE) in 1 CARTON
1118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34110/29/2009
PEDIACARE CHILDRENS ALLERGY 
diphenhydramine hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52183-499
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID 
D&C RED NO. 33 
FD&C RED NO. 40 
GLYCERIN 
POLOXAMER 407 
WATER 
SODIUM BENZOATE 
SODIUM CHLORIDE 
SODIUM CITRATE 
SUCROSE 
Product Characteristics
ColorPINKScore    
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:52183-499-041 BOTTLE (1 BOTTLE) in 1 CARTON
1118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34102/01/2010
Labeler - Blacksmith Brands, Inc. (021411299)
Establishment
NameAddressID/FEIOperations
Trillium Healthcare Products, Inc.255426306MANUFACTURE

Revised: 01/2011
 
Blacksmith Brands, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web3)